Beside usual care the intervention will encourage collaborative practices between staff, patients and family members to adopt more human patient-centred approach on the unit. The intervention is designed to impact on treatment culture and thereby treatment practices on the study wards.

educational intervention

Educational intervention for staff members will encourage collaboration between patients, relatives and staff members. Skills, intellectual resources, motivation and encouragement among staff members to make changes on the unit will be supported. More detailed content of the intervention to be used in each unit will be tailored based on preparatory phase of the study and individual needs of the unit. The educational intervention will be carried out beside usual care.

Additional Information

Official title

The Effectiveness of User-driven Intervention to Manage Patient Aggression in Mental Health Services

Description

This is a single-blind, two-arm cluster randomised controlled trial involving 15 hospitals
with psychiatric hospital beds across Finland.
Units are randomised on an equal basis to receive either staff educational programme
(designed together with staff members, patients and relatives on the study units) or
standard care. Inpatient psychiatric hospital organisations are the unit of randomisation.
The cluster design will be used to avoid contamination between individual staff members in
each study ward. We will use centralized randomisation at the University of Turku
(Department of Mathematics and Statistics). Randomisation will be fully concealed and
computer-generated by an independent statistician, who is not involved in the study.
Investigators enrolling wards cannot foresee assignment. Outcome assessors and statisticians
will be kept blinded to allocation. However, due to the type of intervention, allocation
will be unmasked to patients and their relatives, contact persons in each ward, and health
care staff delivering patient care on the wards after randomisation; this would reflect
real-world care. While the Data Monitoring Committee undertook ongoing safety surveillance,
investigators running the preliminary analysis for the Data Monitoring Committee will be
masked to data until investigators released the database. Further, the statisticians and the
National Register holder who are responsible in Finnish routine data used in this study,
will be masked to ward allocation and patient data in each group. Randomisation will be done
after collecting the baseline data from each unit.
Baseline data on coercive practices used on the units will be collected by the members of
the research team with a help of staff members within the eight weeks, while observational
and interview data related to the quality of the services will be collected by the research
team (only in the intervention units). On the individual level, all staff members working in
the study units, patients, and their relatives are eligible to participate in the study.
Staff survey and interviews with staff members, patient groups and relatives will be done on
the basis of free will. The staff of the unit/research team members will approach patients
and their relatives to explain the purpose of the study and its arrangements orally and in
written format. The opportunity to ask questions about the study will be given to them.
Those that will be assessed having a lack of capacity to give informed consent and declined
to participate will not be interviewed. Staff surveys will be repeated for baseline and
follow-up. On the organisational level, the outcomes related to patient service use will be
assessed 12 months after baseline data collection.
Assessing quality components: The strengths, weaknesses, opportunities, and threats related
to the new practices will also be discussed and categorised based on SWOT analysis
(Strength, Weakness, Opportunity, Threat). Possible barriers and facilitating factors for
change on the on each unit will be identified. The quality of the service facilities will be
assessed by observations on the units, based on World Health Organization's (2012)
QualityRight Tool Kit focusing on five central quality criteria.
Power and sample size: We have systematically searched for, but found no directly relevant
past work. We may assume that about 8 % of all adult patients admitted in psychiatric
hospitals will be coerced during their stay. We may consider 50% reduction for the use of
coercion methods. In order to do this with 80% power at a 5% two-sided significance level
(alpha = 0.05 and 80 % power), about 20 wards with total of 1,764 patients would be
randomised in two arms. The patient related data will be collected in during the
intervention period.

Trial information was received from ClinicalTrials.gov and was last updated in August 2016.